ES2981242T3 - Protective packaging structure for compressible materials and tissue repair kit - Google Patents

Abstract

A more robust packaging structure is provided to maintain the integrity of compressible biologically active materials during storage and, especially, during transport. These containers protect the materials from shock, vibration, deformation, or separation due to shaking. Compressible materials can be in the form of synthetic fibers and may include a composite of fibers and beads or granules. Suitable materials that may benefit from such a robust packaging structure include synthetic materials comprising a biologically active ceramic or glass. (Automatic translation with Google Translate, no legal value)

Description

DESCRIPTION

Protective packaging structure for compressible materials and tissue repair kit

The following non-SI units are used in this specification and can be converted to the respective SI units in accordance with the following conversion table:

1 inch corresponds to 2.54 cm.

1 g/in3 corresponds to 0.061 g/cm3

Technical field

The present disclosure relates to packaging structures for the storage or transport of materials sensitive to shock, vibration, deformation or separation caused by agitation. More specifically, the present disclosure relates to storage containers and packaging methods for the storage or transport of compressible biologically active materials. Even more specifically, these storage containers and associated packaging methods protect compressible biologically active materials, which may include fibers and composite granules, from shock, vibration, deformation or separation caused by agitation during storage and during transport.

Background

Over the past decade, there have been many new advances in the field of tissue regeneration and wound care. One such advance is in the area of materials science and the development of new synthetic graft materials including biologically active ceramics and glass. Today, biologically active glass products in fiber form are available for tissue scaffolding, and have shown great potential in their ability to help regenerate new tissues, including both soft and hard bone tissues, as well as wound dressings. While clinical outcomes have been favorable, the fragile and specifically compressible nature of the products themselves presents a unique challenge in terms of handling, and particularly with storage and transportation.

It is well accepted that packaging of medical devices is as critical as the devices themselves. In addition to the fundamental requirement to maintain device sterility, superior medical technology cannot be delivered if the clinical device arrives damaged. Particularly with compressible synthetic fiber materials for wound care and tissue regeneration, maintaining the integrity of these materials during transport is critical to ensure the product meets advertised product specifications and customer expectations after shipment. Fiberglass materials, especially uncoated, will compress and change shape under their own weight if stored in standard packaging arrangements such as a standard plastic tray sealed with Tyvek or a foil lid, or a clamshell-type plastic container. Vibrations from normal shipping activities can lead to displacement of the fibers in the package, which can lead to alterations in the shape, appearance, and function of the fibrous synthetic product. Shape change is especially critical for wound dressings in the same shelf box, as significant product variation from dressing to dressing leads to loss of customer confidence.

It is therefore desirable to provide improved containers that serve to maintain the integrity of fibrous synthetic materials during storage and especially during transport. These containers must be able to protect the materials from shock, vibration, deformation or separation caused by agitation.

US 2013/233736 discloses a protective packaging with one or more product preparation features comprising a containment unit having a first bottom cover and a second top cover, the first bottom cover including a recess for receiving a compressible material therein, the recess having a surface feature to facilitate containment and reduce movement of the compressible material, and the second top cover being configured to fit against the first bottom cover to form a closed container and create an interior volume within the closed container sufficient to exert a compressive force against the compressible material within the closed container and protect the compressible material from shock, vibration, deformation or separation caused by agitation when within the closed container.

Brief summary

The present disclosure provides a more robust packaging structure for maintaining the integrity of biologically active materials during storage and especially during transportation. These containers protect the materials from shock, vibration, deformation or separation caused by agitation. The materials may be in the form of synthetic fibers, and may include a composite of fibers and beads or granules. According to one aspect of the disclosure, suitable materials that may benefit from such a robust packaging structure include synthetic materials comprising a biologically active ceramic or glass.

In one embodiment of the invention there is provided a protective packaging structure for transporting compressible materials according to claim 1.

In accordance with one aspect of the disclosure, the compressive force may be a mechanical force. The containment unit may be configured to provide a pressure gradient across its surface such that different pressures are exerted against the material residing within the containment unit from region to region, and across the surface area of the material.

Additionally, the containment unit may include various surface features on the top or bottom of the containment unit to help maintain the position of the material and reduce or eliminate any shifting within the containment unit, as well as to provide visual cues for the clinician to measure, cut, or shape the material for clinical use.

In one embodiment, the packaging structure may comprise a containment unit having two voids. In another embodiment, the packaging structure may comprise a containment unit having four voids.

In one embodiment, the packaging structure may comprise first and second covers that are separate components and configured to fit together. In another embodiment, the packaging structure may comprise first and second covers that are connected at one side to form a clamshell. In accordance with one aspect of the disclosure, at least one of the covers may be formed of a transparent material for viewing of the compressible material therein. In accordance with another aspect, the second upper cover may be configured to be screwed to the first lower cover. For example, in one example, the first and second covers may be cylindrical, circular, or round, and include strands for interconnecting with each other. In accordance with yet another aspect of the disclosure, the second upper cover may include a handle.

In one embodiment, the first bottom cover may include surface features comprising spikes, barbs, protrusions, ridges, teeth, an etched surface, or a rough surface. The surface feature of the first bottom cover may reside on a bottom surface of the cover or on a side surface of the cover.

In accordance with one aspect of the disclosure, the first and second covers may be configured to form a reclosable seal when joined together. In accordance with the invention, raised portions on the second top cover create slit marks arranged in a cross pattern to form rectangular geometries. The first and second covers may be configured to form a mold tray for the compressible material when joined together.

In accordance with one aspect of the disclosure, the packaging structure may be useful for compressible materials comprising a porous, fibrous, hydrophilic biologically active material. In accordance with another aspect of the disclosure, the sealed container may be configured to prevent gases, liquids, and debris from passing through it.

In accordance with one aspect of the disclosure, the thickness of the first bottom cover or the second top cover may not be uniform thereacross. In accordance with another aspect of the disclosure, the surface feature of the first bottom cover may be evenly distributed across the entire bottom surface of the cover. In accordance with yet another aspect of the disclosure, the surface feature may create visual cutting guides for cutting the compressible material, and/or may create visual measuring guides for measuring a size of the compressible material.

In one exemplary embodiment, the surface feature of the first lower cover may comprise features of uniform size, while in another exemplary embodiment, the surface feature of the first lower cover may comprise features of non-uniform size.

In accordance with one aspect of the disclosure, the packaging structure creates a sealed container that may be configured to provide a compression force gradient therealong. In accordance with another aspect of the disclosure, the packaging structure may be configured to maintain the compressible material in a sterile condition when sealed.

In another exemplary embodiment of the present disclosure, a kit for tissue repair is provided. The kit may comprise a compressible composition of glass fibers and biologically active beads, and a protective packaging structure for transporting the composition.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and do not limit the disclosure. Additional features of the disclosure will be set forth in part in the description that follows or may be learned by practice of the disclosure. Brief Description of the Drawings

The accompanying drawings, which are incorporated into and made a part of this specification, illustrate various embodiments of the disclosure and, together with the description, serve to explain the principles of the disclosure.

Figures 1A, 1B, and 1C are photographs of prior art packaging structures containing fiberglass wound care dressings after shipment.

Figure 2 is another photograph of a prior art packaging structure containing a fiberglass wound care dressing after shipment.

Figure 3 is a photograph of an exemplary embodiment of a packaging structure of the present disclosure containing a fiberglass wound care dressing.

Figures 4A and 4B illustrate another exemplary embodiment of a packaging structure of the present disclosure, wherein Figure 4A shows a top-down view of a bottom cover, while Figure 4B illustrates a top-down view of a top lid for use with the bottom cover of Figure 4A.

Figures 5A and 5B are photographs of the packaging structure of Figures 4A and 4B containing a fiberglass wound care dressing, wherein Figure 5A shows a photograph of the packaging structure and the fiberglass wound care dressing in a closed state, while Figure 5B shows a photograph of the fiberglass wound care dressing removed from the packaging structure of Figure 5A.

Figure 6 is a cross-sectional view of yet another exemplary embodiment of a packaging structure of the present disclosure containing a fiberglass material.

Figure 7 is a cross-sectional view of yet another exemplary embodiment of a packaging structure of the present disclosure having a gradient of compression forces.

Figure 8 is a cross-sectional view of yet another exemplary embodiment of a packaging structure of the present disclosure having a gradient of compression forces.

Detailed description

The present disclosure provides a more robust packaging structure for maintaining the integrity of biologically active materials during storage and especially during transportation. These containers protect the materials from shock, vibration, deformation, or separation caused by agitation. The materials may be in the form of synthetic fibers, and may include a composite of fibers and beads or granules. In some embodiments, the materials may comprise a biologically active ceramic or glass. For example, fibrous composite materials of the type described in U.S. Patent No. 8,173,154, U.S. Patent No. 8,535,710, and U.S. Patent No. 8,821,919 may benefit from the use of the various packaging structures of the present disclosure.

The improvements in fiber packaging provided in the present disclosure allow for more rigorous handling prior to use. Since the vibration from normal shipping and handling has now been addressed with the improved fiber packaging, new applications of the material are now possible. The fiber material can now be used by individuals such as first responders or military personnel located in theater or forward military positions. The new compression packaging can give the fibers the ability to handle shock and vibration on a regular basis while being carried in a soldier's backpack or driven over rough terrain in a vehicle.

Immobilization of synthetic fibers, particularly compressible synthetic fiber materials comprising bioactive glass or ceramic for wound care dressing and tissue regeneration, is critical to ensure that the product meets advertised product specifications and customer expectations after shipment. Fiberglass materials, especially uncoated, will compress and change shape under their own weight if stored in standard packaging arrangements such as a standard plastic tray sealed with a Tyvek or foil lid, or a clamshell-type plastic container. Vibrations from normal shipping activities can lead to fiber displacement in the package, which can result in alterations in the shape, appearance, and function of the wound care product. Shape change is especially critical for dressings in the same shelf box, as significant product variation from dressing to dressing leads to loss of customer confidence.

Turning now to the illustrations, Figures 1A, 1B, and 1C depict photographs of three individual fiberglass dressings 100 stored in prior art single-unit containers 2 that were removed from an individual shelf box after standard shipment. That is, each of the single-unit containers 2 were shipped together in the same box. As clearly shown in the photographs, the range in appearance and size of the contents varies from one container 2 to the next, even though these containers 2 were shipped at the same time and in the same box. The left unit (Figure 1A) shows approximately 100% fill, while the middle unit (Figure 1B) shows approximately 90% fill, and the right unit (Figure 1C) shows approximately 75% fill. In addition, noticeable wrinkles and creases are formed in the dressing 100 in Figure 1C on the right. Furthermore, there is evidence of the fiber material separating or breaking apart, as seen in the same dressing 100 of Figure 1C. Thus, it is clear that each of the three dressings 100 contained within the single unit containers 2 of Figures 1A, 1B, and 1C are noticeably different in size and have varying levels of creasing or wrinkling, despite having the same contents (including size and volume of contents) in the shipment, and being shipped together at the same time.

As Figure 2 further illustrates, the presence of free-flowing beads 102 that have separated from the dressing 100 and accumulated in the lower left corner of the prior art container 2 represents another significant problem with present-day prior art packaging. The Tyvek lid provides minimal compression closing the retention tray of the prior art container 2, and even a plastic clamshell-type design offers minimal compression after initial closure. When the container is agitated or shocked during transport, the jostling action can cause the fiber materials, some of which are composites of bioactive glass fibers and beads, to separate in the same manner that a centrifuge would cause a mixture of different components of different densities to separate.

To overcome these problems with currently existing packaging, the present disclosure provides a more robust packaging structure 10 to maintain the integrity of compressible biologically active materials 100 during storage and especially during transportation. These containers 10 protect the materials 100 from shock, vibration, deformation or separation caused by agitation. In accordance with one aspect of the disclosure, one solution is to maintain the dressing in a constant state of compression to ensure that the dressing does not change shape or lose its function during shipping.

In an exemplary embodiment illustrated in Figure 3, the packaging structure 10 may comprise a first bottom cover or tray 20 and a second top cover or lid 40. The first bottom cover 20 may be defined by a bottom surface 22 surrounded by side walls 24 and include one or more recesses 30 for receiving a compressible material 100 such as a fibrous bioactive glass material for wound care or tissue regeneration dressing. The second top cover 40 may be defined by a top surface 42 surrounded by side walls 44 and configured to fit against the first bottom cover 20 to form a closed container. In accordance with one aspect of the disclosure, the closed container may be configured to exert a compressive force against the compressive material therein, and protect the compressive material 100 from shock, vibration, deformation or separation caused by agitation, within the closed container 10. The compressive force may be a vacuum force or a mechanical force, as will be described in detail below.

The packaging structure 10 illustrated in Figure 3 comprises a two-piece cover design that snap together, placing the fiber dressing 100 in a compressed state. Compression can be achieved by forming a fiber pad with a bulk density of ~0.3051 g/cm3 (5 g/in3). As shown, the two pieces of the packaging structure 10 can be separate components that are configured to snap together or interconnect. Of course, it is understood that the two pieces can also share a common side, or connect at an edge, to form a clamshell-type containment unit. It is also contemplated that the covers 20, 40 can include threads 32 and be configured to screw together, the top cover can be screwed into the bottom cover at an interconnecting joint, for example, as shown in the exemplary embodiment in Figure 6. The covers 20, 40 can be round in shape. If desired, the top cover 40 may also include a lip or handle 46 for ease of handling (see FIG. 6 ). Similarly, the bottom cover 20 may have a lip, flange, or other gripping portion 26 for convenient handling. In some embodiments, the packaging structure 10 may be resealable, and the first and second covers 20, 40 may form a resealable seal when joined together. In other embodiments, the packaging structure 10 may be configured to maintain the sterility of its contents until the seal is broken, and thus would not be resealable.

As shown in the exemplary embodiment of Figure 3, the lower tray 20 may comprise a single recess 30 for a single dressing or pad unit 100. However, it is understood that the tray 20 may comprise more than one recess 30, and for example may comprise two or four recesses, as will be shown in other examples herein. In one embodiment, the recess 30 may measure approximately 5.08 cm x 5.08 cm (2 inches x 2 inches) and form a square shape. However, other shapes and sizes for the recess, such as a rectangle or circle, are also contemplated.

In addition, one or more of the covers 20, 40 may be formed of a transparent or translucent material so that the contents are clearly visible. The packaging structure 10 shown in Figure 3 comprises bottom and top covers (or tray and lid) 20, 40, both formed of a transparent material for viewing of the compressible material 100 within. Each of the covers 20, 40 may be formed of a plastic material and configured to prevent gases, liquids and debris from entering the void 30 and contaminating or damaging the materials 100, which may be porous and/or hydrophilic and therefore susceptible to moisture.

The packaging structure of Figure 3 provides a compressive force against the material 100 in the range of about 0.3051 g/cm3 (5 g/in3), for example. This compressive force is created when the upper and lower covers 20, 40 are brought together and create a mechanical force or pressure that is exerted against the compressible material 100 contained therein. Alternatively or additionally, a vacuum force may also be used to create the compressive force. Accordingly, the containment unit or packaging structure may be considered to act as a mold tray.

In the exemplary embodiment of Figure 3, both covers 20, 40 of the packaging structure 10 are smooth. In other embodiments, however, one or more of the covers 20, 40 may not be smooth. In addition to the immobilization of the fibrous material 100 that comes from the covers 20, 40 once pressed together, dimensional features molded into the plastic covers 20, 40 may enhance immobilization by adding additional compression to the dressing or materials 100. In some embodiments, each of the voids 30 of the covers 20 may have a surface feature to facilitate containment and reduce movement of the compressible material 100 within the voids. For example, patterns molded into the top and bottom of the covers 20, 40 act as teeth to impart a gripping characteristic to the otherwise smooth plastic surface.

As an example, Figures 4A and 4B illustrate another exemplary embodiment of a packaging structure 110. Packaging structure 110 shares the same features of packaging structure 10, with similar reference numerals representing the same features. Figure 4B shows a raised surface forming a transverse pattern 48 on the top surface 42 of the top cover or lid 40, while Figure 4A shows a raised surface forming a dimpled array 28 on the bottom surface 22 of the bottom cover or tray 20. The added compression features 28, 48 on the covers 20, 40 reduce movement of the dressing 100 during shipping without noticeable changes in dimensions or loss of beads 102 of the fiber matrix material 100. Another embodiment may have a raised surface pattern covering part or all of the top and/or bottom surface of each cover 20, 40, in order to add surface attachment or grip enhancement throughout the fiber dressing 100, rather than a flat surface. It is envisioned that any feature that imparts a force in a localized area may be incorporated into the embodiments described herein. For example, another embodiment may use both the patterns and the textured surface.

Suitable compression or surface features may include, for example, spikes, barbs, protrusions, ridges, teeth, embossments, or surface roughness. These surface features may be found on the bottom of the first bottom cover 20. However, surface features may also be provided on the side surfaces 24 of the recess 30, as well as on the second top cover 40. The compression features of the packaging structure 10 of Figures 4A and 4B are evenly distributed across the bottom of the bottom cover 20. In the example shown, the dimples 28 are evenly spaced approximately 1.27 cm (0.5 inches) apart. However, it is contemplated that in other embodiments the compression features may be arranged in a non-uniform array or pattern, to provide a gradient of compression forces across the packaging structure 10. For example, the compression features may be arranged in a starburst pattern, with a greater concentration of the features in the center, as the features radiate toward the edges. In another embodiment, the compression features may all be of uniform size. In yet another embodiment, the compression features may be of different size from one another, to create a non-uniform compression force within the packaging structure 20. In still other embodiments, the type, shape, or style of the compression features may not be uniform, such that a combination of different features may be used on the same cover, such as, for example, a combination of dimples and embossments arranged uniformly or non-uniformly across the covers 20, 40.

In another aspect of the disclosure, certain features of the fiber immobilization system may further assist the clinician in applying the dressing.

In accordance with the invention, as shown in Figure 4B, the top cover or lid 40 has raised portions 48 to define discrete geometries of the compressible material. These raised portions create indentation marks 48 such that, when used with the compressible material as shown in Figure 5A, the cross pattern of the raised portions 48 integrated into the top piece of the packaging structure 10 can actually impart some indentations in the dressing 100 that make separation of the material 100 into four (4) 2x2 dressings or squares of material simpler, and eliminates the need for scissors. These indentation marks 48 can define discrete geometries such as a square or rectangular shape, and as shown, can provide indentation marks in the material 100 that serve to score the material to facilitate separation. Figure 5B shows how the material is easily separated into these discrete geometries without the need for cutting tools. In this manner, the packaging structure 10 of the present disclosure also serves as a molding tray, allowing the materials 100 to be maintained in a defined shape during storage and transportation until use.

As shown, the dimple marks 48 can create distinct squares of materials for use as dressings or tissue scaffolds. However, other dimple configurations could be used, but the concept is the same to add functionality by immobilizing the dressing until use and allowing the clinician to more easily tailor the dressing to the patient's needs. In addition, the dimples 28 formed on the bottom of the dressing would allow the clinician to have a visual measuring tool as well as a cutting guide for cutting shapes that are not defined by the top transverse slit 48. For example, for a wound that was 6.35 cm (2.5") long, a 1.27 cm (0.5 inch) dimple arrangement would allow the clinician to simply count 5 of the dimples and cut, rather than trying to somehow measure and mark the dressing before cutting. These additions save time for the clinician and increase value, especially in surgery where time is critical.

The packaging structures of the present disclosure may be configured to provide compression of the fiber material to an average bulk density in the range of: about 0.0305 g/cm3 (0.5 g/in3) to 1.2204 g/cm3 (20 g/in3), or about 0.0610 g/cm3 (1 g/in3) to 0.6102 g/cm3 (10 g/in3), or even about 0.1220 g/cm3 (2 g/in3) to 0.3051 g/cm3 (5 g/in3). As depicted in Figure 6, in another exemplary embodiment, the packaging structure 210 may provide a uniform compression force against the fiber material 100 contained therein. This can be accomplished with a packaging structure 210 that employs threads 32 to allow the upper cover 40 to be secured to the lower cover 20, and exert an even and uniform force on the contained material 100 once the two covers 20, 40 are joined together.

However, in another aspect of the present disclosure, the packaging structures may be configured to provide a gradient of compression pressures against the fiber material 100. This may be achieved, for example, by using a fiber density gradient for attachment, or by using multiple (i.e., two or more) modes of compression with different density profiles to mechanically attach the fiber material 100. Examples of multiple compression density modes may be achieved by using a combination of features such as the flat surface, cross groove 48, or dimpled surface 28 to affect fiber density.

Figures 7 and 8 illustrate exemplary embodiments of packaging structures that provide a gradient of compression forces on the material contained therein. As shown, various fiber densities due to compression can be achieved by providing a higher average density in one region compared to another region of the same packaging structure by adjusting the amount of compression in that region. One way to achieve the different compression force is to vary the thickness of either one or both of the covers 20, 40. For example, as Figure 7 illustrates, a raised portion in the center of the top cover 40 would create a greater compression force or compression point (CP) in that region when the two covers 20, 40 are joined together. As Figure 8 illustrates, additional smaller raised portions can be provided on the bottom cover 20 that, when used with the top cover 40 of Figure 7, would create a gradient of compression pressures (all due to the mechanical force exerted against the fiber material) across the surface of the packaging structure. As shown, CP compression points vary and can range from 0.3661 g/cm3 (6 g/in3) to 0.6102 g/cm3 (10 g/in3) in different regions of the packing structure.

Kits for tissue repair may be provided that would include the packaging structure disclosed herein along with a compressible fibrous material suitable for tissue repair and wound care dressing, such as a composition of glass fibers and biologically active beads. The packaging structure comprises a closed container that could prevent separation of the fibers and beads caused by shock or vibration, such as during transportation and helps maintain the materials in a sterile condition.

Other embodiments will be apparent to those skilled in the art from consideration of the specification and practice of the embodiment disclosed herein. The specification and examples are intended to be considered by way of example only, with a true scope of the embodiment being indicated by the following claims.

Claims (14)

1. A protective packaging structure (110) for transporting compressible materials (100), the structure comprising: a containment unit having a first lower cover (20) and a second upper cover (40), the first lower cover (20) including one or more voids (30) for receiving a compressible material (100) therein, each of the one or more voids (30) having a surface feature (28) to facilitate containment and reduce movement of the compressible material (100) within the one or more voids (30), and the second upper cover (40) being configured to fit against the first lower cover (20) to form a closed container, the upper cover (40) further having raised portions (48) configured to define discrete geometries of the compressible material (100), wherein the first lower cover (20) and the second upper cover (40) are configured to join together and create an interior volume within the closed container sufficient to exert a compressive force against the compressible material (100) within the closed container and protect the compressible material from shock, vibration, deformation or separation caused by agitation when within the closed container; and wherein each of the raised portions comprises substantially linear raised indentation marks (48) arranged in a criss-cross pattern to form rectangular geometries. 2. The packaging structure (110) of claim 1, wherein the compression force comprises a mechanical pressure. 3. The packaging structure (110) of claim 1, wherein the first (20) and second (40) covers are separate components and are configured to fit together. 4. The packaging structure (110) of claim 1, wherein the first (20) and second (40) covers are connected at one side to form a clamshell. 5. The packaging structure (110) of claim 1, wherein at least one of the covers (20, 40) is formed of a transparent material for viewing the compressible material (100) therein. 6. The packaging structure (110) of claim 1, wherein the surface feature (28) of the first bottom cover comprises at least one of points, spikes, protrusions, ridges, teeth, an embossed surface or a rough surface. 7. The packaging structure (110) of claim 1, wherein the surface feature (28) of the first bottom cover (20) resides on a bottom surface (22) of the cover, optionally wherein the surface feature (28) of the first bottom cover (20) is evenly distributed across the bottom surface (22) of the cover, optionally wherein the surface feature (28) creates visual cutting guides for cutting the compressible material (100), or wherein the surface feature (28) creates visual measurement guides for measuring a size of the compressible material (100), or wherein the surface feature (28) of the first bottom cover (20) resides on a side surface (24) of the cover. 8. The packaging structure (110) of claim 1, wherein the first (20) and second (40) covers form a resealable seal when joined together. 9. The packaging structure (110) of claim 1, wherein the substantially linear raised portion (48) comprises a first substantially linear raised portion and a second substantially linear raised portion. 10. The packaging structure (110) of claim 9, wherein the first and second substantially linear raised portions intersect each other to form four voids (30) within the closed container. 11. The packaging structure (110) of claim 1, wherein the first (20) and second (40) covers are configured to form a mold tray for the compressible material (100) when joined together. 12. The packaging structure (110) of claim 1, wherein the sealed container prevents gases, liquids and debris from passing through it. 13. The packaging structure (110) of claim 1, further configured to maintain the compressible material (100) in a sterile condition when sealed. 14. A tissue repair kit, comprising: a compressible composition (100) of glass fibers and biologically active beads; and a protective packaging structure (110) for transporting the composition according to any preceding claim.